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### January 2 7 , 2016 Antimicrobial Pesticides Use Site Index



## I. Introduction

T he Environmental Protection Agency (the Ag ency ) codified twelve antimicrobial use patterns in 40 CFR part 158 , subpart W (referred to as “Part 158W”)

. T he A gency has developed an Antimicrobial Pesticide Use Site Index (USI) to provide guidance about the antimicrobial pesticide use sites associated with these antimicrobial pesticide use patterns

. Th e USI is a guidance document to assist applicants in ident ify ing the data that are necessary to support registration of products and to determine if labeled uses necessitate establishment of a tolerance or exemption from the requirement of a tolerance

. As noted in 40 CFR Section 158.100(d), the USI will be updated periodically , as needed

.

T he association of a particular antimi crobial use site with an antimicrobial pesticide use pattern should be viewed as a recommendation only and is not to be construed as binding on either EPA or any outside parties

. EPA may depart from the guidance where circumstances warrant and without prior notice.

Pesticide product label ing provide s critical information about pesticide use sites, as well as how to safely and effectively handle and use pesticide products. In order to ensure no unreasonable adverse effects on human health or the environment, FIFRA and its regulations require , among other things, that product label ing specifically state s where and how a pesticide is intend ed to be used

. Where a pesticide is to be used is generally referred to as the “ pesticide use site. ” For antimicrobial pesticides, the use sites are diverse and constant ly evolving as new products are developed

. The USI serves as a guide to the general types of use sites that are commonly listed on antimicrobial labels. It is not intended as an exhaustive list of all possible antimicrobial use sites

. The use sites are organized into twelve use patterns which are used to delineate data requiremen ts in Part 158W.

Furthermore, t he use sites associated with the twelve use patterns are organized into three food use categories : direct food uses, indirect food uses, and nonfood uses. A number of the data requirements in subpart W depend on this categ orization

. The categorization is dependent on the context of the label and a determination of whether residues of the pesticide product have the potential to come into contact with food, either directly or indirectly. For example, within the use pattern Residential and Public Access
Premises

, the use site of Household/Domestic Dwellings is listed under both the indirect food use subcategory as well as the nonfood use subcategory. S pecific ally, there are two use sites : Household/Domestic Dwellings (food h andling areas)

, listed under “indirect food,” and Household/Domestic Dwellings (non

- food handling areas) , listed under “nonfood ”

. This reflects the fact that within the use site category of Household/Domestic Dwellings , there is a potential for indirect f ood contact for some uses (e. g ., if a product is labeled for use on kitchen countertops), but there are also uses within this category that would be considered nonfood (e.g., a product labeled for use as a toilet bowl disinfectant ). The categorization of the use s ites on the product label determine s whether or not certain data requirements must be addressed.

To aid applicants, the d escriptions of the food use categories, direct food, indirect food, and nonfood are listed below. F ood has the same meaning a s the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. § 321(f): (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.Page 2 of 8 

### Direct Food Use

A use is generally considered to b e a direct food use if an antimicrobial pesticide is intended to be directly applied to food or applied to a material or article for the purpose of treating food. Use site s that fall into this category include, but are not limited to: fruit and vegetable rinses, fogging of poultry areas, and egg washing treatments. These types of uses are generally subject to a FFDCA clearance

.

Indirect Food Use

A use is generally cons idered to be an indirect food use if the use involves application of the antimicrobial pesticide in or on a material or article that comes into contact with food and may result in residues in or on food, but the use is not intended for pesticidal treatment of food. As a result of contact with a surface and/or material that has been treated and/or impregnated with an antimicrobial pesticide, there is a potential for transfer of residues in or on food. Use site s that fall into this category include, but are not limited to: sanitization of food

- contact dishes, utensils, food

- processing equipment

, and countertops; disinfection of food

- use areas; and impregnation of cutting boards, conveyor belts

, or food containers and/or packaging for a pesticidal purpose oth er than treating food (e.g., to protect the article itself from degradation by bacteria) . These types of uses may be subject to a FFDCA clearance

.

Nonfood Use A use is generally considered to be a nonfood use if the antimicrobial pesticide is not expect ed to come into contact (directly or indirectly) with food as a result of its intended use and, therefore, there is no reasonable expectation of residues in/on food. Use site s that fall into this category include, but are not limited to: fuel tanks, hum an footwear, or nonfood areas (e.g., under the sink) of eating establishments. These types of uses are not subject to a FFDCA clearance.



## II. How to Use this Use Site Index to Determine Data Requirements

The applicant should follow these basic steps for using the Use Site Index :

1. Look for use sites in the USI that are similar to your proposed uses

. 2. Identify which of the use patt erns applies to your proposed uses. 3. For ecological data requirements, consult the Nontarget Organism, Nontarget Plant Protection

, and Environmental Fate Data Requirement Tables in Part 158W to determine data required for each use pattern . For example, Guideline Number 850.3020, Honeybee Acute Contact Data

, are Required (R) for Wood Preservatives, Not Required (NR) for Industrial Process es and Water Systems and Antifoulant Paints and Coatings , but Conditionally Required (CR) for the All Other Use Pattern Categor ies

. 4. For human health (toxicology and residue chemistry) data requirements , determine the food use category of your proposed uses by :

a. Identifying whether your proposed use sites are characterized as “direct food”, “indirect food”, or “nonfood” based on the designation of the similar use sites listed in the USI. b. A pplying the guidance in Section III ( Figure 1. Food Use Description Flow Chart) to the proposed uses to determine whether a tolerance/tolerance exemption is needed. 5. For exposure data requirements, consult the Antimicrobial Applicator Exposure Data Requirements table and the Antimicrobial Post

- Application Exposu re Data Requirements tables to determine the data required according to whether the use pattern is associated with occupational or residential exposure.Page 3 of 8 

## III. How to Determin e Required FFDCA Clearances

This USI provides guidance on whether a use site on a product label will necessitate establishing a tolerance or tolerance exemption (see Figure 1).

FFDCA clearances will be required where there is a reasonable expectation of residues in or on food as a result of application (either directly or indirectly) o f the pesticide to food and the food moves in interstate

commerce. For a substance that meets the definition of “pesticide chemical residue” under FFDCA section 201(q), a tolerance or exemption from the requirement of a tolerance will be required; for a

s ubstance that is excluded from that definition, the US Food and Drug Administration (FDA) may need to issue a food additive regulation or food contact notification. Regardless of the classification under 201(q), residues of pesticides in or on foods will cause foods to be considered adulterated and subject to seizure if appropriate FFDCA clearance(s) are not in place (i.e., a tolerance, tolerance exemption, FDA food additive regulation, and/or food contact notification (FCN)). See 21 U.S.C. §§ 334, 342, 3 46a, and 348.

EPA has made it a requirement of FIFRA registration that, if a pesticide bears directions for use on food or may be reasonabl y expected to result in residues on food which moves in commerce, all necessary FFDCA clearances must be in place

. 40 C.F.R. § 152.112 (g). Because direct food use pesticides, by definition, contain label directions for use on food, all necessary clearances under the FFDCA must be in place to obtain FIFRA registration. Because indirect food uses are generally consider ed to have a reasonable expectation for residues on food, all necessary clearances under the FFDCA also must be in place to obtain a FIFRA registration. However, EPA will not require that FFDCA clearances be obtained for indirect food uses if an applicant can demonstrate that the use (s) of a particular product do not have a reasonable expectation of resulting in residues on food. No FFDCA clearances are required for nonfood uses because there is no reasonable expectation of residues on food for these uses

.
Figure 1 below assumes that a determination under FFDCA section 201(q) has been made and the residues in/on food would meet the definition of pesticide chemical residues

. T herefore, EPA would ha ve jurisdiction under FFDCA section 408 to determine if a tolerance or exemption from the requirement of a tolerance is needed

. For residues that do not meet the definition of “ pesticide chemical residue ” and are under the jurisdiction of FDA under FFDCA section 409, EPA still must make a safety finding by conducting any appropriate dietary exposure assessments if the residues result from the use of FIFRA

registered pesticides. This flow chart is not designed to delineate jurisdiction under FFDCA between EPA and FDA.Page 4 of 8 

### Figure 1. Food Use Description Flow Chart

No data required to support

a dietary assessment 

# Direct
Food Use Indirect
Food Use Nonf ood

Use

Are residues expected
in/on food for this use ? Are residues expected
in/on food for this use? No residues expected
in/on food for this use

No

Yes

Is the use strictly residential?

Yes No

D ata are necessary to support a d ietary exposure
assessment conducted for

safety finding (FIFRA)

A tolerance or exemption from the requirement of a tolerance is needed No tolerance or exemption from the requirement of a tolerance is needed Registrant must

pr ovide an

adequate
rationale and/or
demonstrate that
there is no
reasonable expectation of
residues in/on
food *

*Examples of rationale include but are not limited to:

• Data and/or rationale used to support FDA food additive regulation or FCN

• Theoretical high

- end calculations/modeling demonstrating that 

### there is no reasonable expectation of residues in/on food

• Data/justification of residue removal via a potable water rinse

• Label restrictions limiting exposure to food

• Justification based on product chemistry and/or environmental fate characteristics (i.e., volatility, solubility)

• Residue dataPage 5 of 8 

## IV. Use Site Index

Food Uses Nonfood Uses

Direct Food Uses Indirect Food Uses

1. Agricultural Premises and Equipment

− Irrigation Systems (Food crops) − Animal Drinking W a ter

− Animal Premises/Structures/Buildings/ Equipment

− Beehives (honey producing)

− Dairy Farm Milk Handling

− Empty Containers or Equipment to Be Used for Raw Agricultural Commodities

− Facil i ties/Equipment

− Fish Hatchery Buildings/Areas (Nonaquatic)

− Food/Feed Storage Premises

− Greenhouses (Food Crops) − Agricultural/Farm Premises/Structures/Buildings/ Equipment

− Beehives (non

- honey producing

, such as pollinators)

− Egg Handling Equipment/Rooms/Washing/Treatments (Hatching)

− Greenhouses (Nonfood crops)

− Irrigation Systems (Nonfood crops)

− Shoe Baths

− Tobacco Processing Plant Premises/Equipment

2. Food Handling/Storage Establishments, Premises and Equipment

− Egg W a shing
Treatments

− Fruit and Vegetable
Treatments − Dairies/Cheese Processing Plant Premises/ E quipment

− Dish w a shing W a ter

− Eating Establishments/Equipment/Utensils/Food Handling/Serving Areas

− Egg Handling Equipment/Handling Rooms/Packing Plants

− Feed Mills/Food Processing Plants Premises and Equipment

− Food Processing W a ter Systems

− Transportation/Facil i ties/ Barges / Railroad Car s/ Commercial Shipping Containers − Eating Establishments (Nonfood areas)

− Food Processing Plant Premises/Equipment (Nonfood)

− Hydrostatic Sterilizer W a ter Systems

− Pasteurizer/ W armer/Cannery/Retort W a ter Systems

3. Commercial, Institutional and Industrial Premises and Equipment Not Applicable Not Applicable

− Barber/Beauty Shop Equipment/Instruments

− Commercial Transportation Vehicles/Facilities

− Heating, Ventilation, and Air Cond i tioning (HVAC) Systems

− Laundry/Laundry Equipment

− Premises/Equipment

− Refuse/S olid W a ste Transportation Facilities/Handling Equipment
4. Residential and Public Access Premises Fruit and Vegetable
Treatments − Household/Domestic D w ell i ngs (Food Handling Areas such as kitchens ) − Air Treatments

− Animal Kennels/Pet Living/Sleeping Quarters

− Automobiles, Taxis, Limousines, Recreational Vehicles (RVs)

− Bathroom Premises

− Clothing/Laundry

− HVAC Systems and HumidifiersPage 6 of 8 

## Food Uses Nonfood Uses

Direct Food Uses Indirect Food Uses

− Public Areas Contents/Premises

− Household/Domestic D w ellings Contents/Premises (non

- food handling

areas such as bathrooms )

− Paths/Patios/Paved Areas

− Public Areas Contents/Premises

− Refuse/Solid W a ste Containers/Equipment/Facilities/Sites

− Toilets (Urinals, Latrines, W ater Closets)
5. Medical Premises and Equipment Not applicable Not applicable

− Air Treatments

− Ambulances

− Hospitals/Medical Institutions (Human/Veterinary nonfood handling areas )

− Critical and Noncritical items (patient care items and noncritical environmental surfaces)

− Medical Waste

− Morgues/Mortuaries/Autopsy/Embalming Room Premises/Equipment

− Nursing Homes/Ass isted Living Facilities (nonfood handling areas)
6. Human Drinking W ater Systems Not applicable Not applicable

− Dental water lines

− Emergency Water Systems

− Individual Water Systems

− Public W a ter Systems

− Reverse Osmosis Water Systems

− W a ter Purifier Units
7. Materials Preservatives Preservative of pesticide formulations applied to growing crops or crops after harvest − Adhesives/Coatings/Caulks (with potential to contact food)

− Cleaning Products ( kitchen food contact surfaces)

− Dispersions/Emulsions/Solutions/ Suspensions (with potential to contact food)

− Paper/Paperboard (with potential to contact food)

− Plastic/Rubber Products ( cutting boards, counter tops) Arts & Crafts Materials , such as finger paints, crayons, colored chalk, pencils Construction Materials , such as adhesives/paints and coatings/caulks not in contact with food, wallboard, ceiling tiles, flooring, Heating/Ventilating/Air Conditioning (HVAC) system filters and other components, pipes (non

potable), mastics, joint compounds, grouting, cements, concrete admixes Disposable Diapers Industrial Matrices , such as metal working cutting fluids (MWFs), metal cleaning fluids, inks /dyes , fuels/oils, dispersions/emulsions/solutions/suspensions, slurries/pastes/gels, fuel and oil storage tanks, recovery drilling muds/packer fluids, polymers, resins, rubber, fracturing fluids, injection, well squeeze, insulation, refuse containers,

mo u lded articlesPage 7 of 8 

## Food Uses Nonfood Uses

Direct Food Uses Indirect Food Uses

Nonfood pesticide formulations

, such as lawns, crack and crevice pesticides, rodenticides, and human and pet treatments (e.g., fleas, lice, scabies, pet collars) Paper and Paperboard Nonfood Contact Materials Plastic and Rubber Nonfood Contact Materials

, such as barrier fabric, shower curtain, cable/wire insulation, non

- food contai ners, mo u lded articles Textiles

, such as clothing, footwear, bedding, cloth diapers, fibers, cordage, tarps, tents, awnings, auxiliaries (sizing/finishing agents), leather/hides, feathers, felt, carpets and padding, canvas, drapes, filters, shower curtains

, rayon, yarn, cloth, insulation, wall and floor covering
8. Industrial Processes and W ater Systems Not applicable

− Pulp/Paper Mill W a ter Systems (food contact paper)

− Air Conditioner/Refrigeration Condensate W a ter Systems

− Air W a sher W a ter Systems

− Bilge Water

− Coal Slurry Systems

− Commercial/Industrial Cooling W a ter Systems[Recirculating/Once Through]

− Evaporative Condenser W a ter Systems

− Gas/Oil Equipment/Fluids

− HVAC Systems

− Industrial Processing Water/Fluid Systems

− Industrial Waste and Waste Water Systems

− Industrial Drainage Systems

− Influent W a ter Filtration Systems

− Industrial Scrubbing System

− Pulp/Paper/Textile Mill W a ter Systems (e.g., newspaper print, magazine print)

− Reverse Osmosis W a ter System (Non potable water)
9. Antifoulant Paints and Coatings Not applicable

− Nets Used for Aquaculture

− Ballast W a ter Treatments

− Aquatic Vessel Coatings

− Aquatic Structures/Equipment

− Crab/Lobster Pots
10. Wood Preservatives Not applicable Packing, transporting, or holding containers for raw agricultural commodities made from treated wood as per 21CFR178.3800 Above Ground , including trusses, millwork, siding and trim; furniture, decking, railings, flooring

, fence pickets , and grape trellises, etc. Ground Contact , including fence, deck and guardrail posts, crossties, permanent wood foundations, buildings poles, posts, utility poles, ties, freshwater piling, raised garden bedsPage 8 of 8 

## Food Uses Nonfood Uses

Direct Food Uses Indirect Food Uses

Marine Use , including piling, bulkheads, bracing

11. S w imming Pools and Spas Not applicable Not applicable

− Spa and Hot Tub Water Systems

− S w imming Pool W a ter Systems

− Water Parks W a ter Systems
12. Aquatic Areas Commercial Fishery
W a ter Systems Agricultural Drainage Systems Intermittently Flooded Areas/ W a ter (rice paddies, cranberry bogs) − Lakes/Ponds/Reservoirs

− Ornamental Ponds/Aquaria

− Salt Water Sites

− Streams/Rivers/Channeled Water